Surgery is generally considered to involve three separate periods, the preoperative period, the intraoperative period and the postoperative period. The preoperative period covers a short period of time, anywhere from about 30 minutes to an hour or more, immediately preceding the intraoperative period.
In the intraoperative period, the surgical procedure or operation is performed with the time involved being anywhere from less than 30 minutes to a number of hours. During some surgical procedures, the patient may be placed under general anesthesia and completely unconscious. During other types of surgical procedures, the patient may be only lightly sedated or receive local or regional anesthesia.
The third postoperative period of surgery is the time immediately following the surgical procedure when the patient is moved to a recovery room or intensive care unit generally for an hour or more. The patient remains here until the effects of the anesthesia or sedation are dissipated and his or her condition stabilizes.
Together, these periods beginning with the preoperative period, continuing into the intraoperative period and concluding at the end of the postoperative period are referred to as the perioperative period.
Doctors and others involved with surgical patients have for some time recognized that the mental and emotional condition of a surgical patient can significantly affect the nature and time of recovery postoperatively. The literature demonstrates the positive effects of good psychological preparation prior to surgery.
Also, applicant is aware of the availability through commercial sale of two tapes for use by patients outside the hospital environment before surgery to aid the patient through the upcoming hospital stay. Such tapes are not prescribed by the medical staff performing the surgery. They include, as background, classical music played on a flute and a stringed instrument, together with voice-over suggestions and instructions urging the patient to relax and explaining in general terms the forthcoming surgical procedure. If the listener is familiar with the music, the effect could be either pleasing or not, depending upon the listener's past association with it. Similar tapes are available for sale to the patient in the weeks following surgery. Again, these tapes include similar music and voice instruction suggesting how to relax and thereby shorten the recovery time.
The literature also shows that during the actual surgical procedure, a patient under general anesthesia has the ability to hear and that the unconscious mind registers meaningful sounds, silence, and operating room conversations. There have only been a few studies conducted which document the effects of voice suggestions by a surgeon and anesthesiologist to patients during surgery.
One such study is discussed in an article published in The Lancet, Aug. 27, 1988, pages 491-493, entitled Improved Recovery and Reduced Postoperative Stay After Therapeutic Suggestions During General Anesthesia. The authors of the Lancet article, Carlton Evans and P. H. Richardson, describe a study they made of the use of tape recorded messages given to a group of patients only during the intraoperative period of surgery. The tape message was played to the patient during surgery and while under general anesthesia. A conventional auto-reverse tape player was used, with headphones making the operating theater sounds inaudible to the patient.
The beginning of the tape used in the Evans/Richardson study played music composed by Pachobel for the purpose of assuring that the tape was properly functioning before the message started. Being familiar music, the effect could be either pleasing or not, depending upon the patient's past association with it. It was not played for therapeutic purposes. The music was followed by three voice sections. The first section casually offered information about the surgery and described the normal postoperative procedure the patient would encounter and gave advice as to how to cope with this phase of the surgery by relaxing. As quoted in The Lancet, the transcript of the study reflects that the tape in this section stated, among other things, the following: "This is not a major operation . . . " Such a statement to a patient would not be permitted in this country because of its lack of universality, i.e., the variable kinds of surgery, health of patients, diagnoses and outcomes make one such general statement inappropriate and inaccurate. An operation may be major to some patients and minor to others. The transcript also reflects a statement in the tape to the effect that the surgery will "make you completely well again." Again, such a statement would not be permitted in this country, because no surgical procedure is uniformly so successful. This was followed by a second voice section containing therapeutic directives such as "you will feel fine", "you will not have any pain", and "your operation is a complete success." Finally, the tape concluded with suggestions to the patient by a member of the operating room staff to the effect that the operation is going well and that the patient is doing fine. Tapes of the nature used in the Evans/Richardson study would not be permitted in hospitals today in the United States, because one would not be permitted to offer to patients general comments, which will not be true for each and every such patient.
The results of the Evans/Richardson study were that patients using the tape recorded message spent significantly less time in the hospital after surgery than those who listened to a blank tape.
The literature further documents the value of music to sedate a person and the specific ways in which music, without extremes in rhythm, melody or dynamics and without familiarity or memory association, works to calm the listener. Such music is referred to as "anxiolytic" in that its purpose is to reduce anxiety. It differs from usual music which creates tension and then resolves such tension. Also, others well known in the mind/body field (i.e. experts in relaxation response, meditation, guided imagery, psychoneuroimmunology) have devised progressive relaxation and guided imagery techniques and other aids to help patients identify physical tension and learn how to relax. Guided imagery involves, for example, suggesting a safe or comfortable place such as a beach or other activity or locale familiar to the listener where the person can relax, such as a walk in the woods or a meadow, or resting in a room of your own with your own personal images and memory.
None of the prior art discloses the use of music, and particularly anxiolytic music, with voice-over information and suggestions for use by the patient through the perioperative period, that is, beginning with the preoperative period, continuing into the intraoperative period and concluding at the end of the postoperative period. Moreover, the prior art fails to disclose a voice delivery which is soft and slow with pauses to allow the patient to assimilate and follow what he is hearing. This is important in that patients under sedation or anesthesia, who may also feel anxious and fearful, tend to have difficulty understanding, assimilating, following or recalling the spoken word.